FDA Medical Device Recalls (openFDA)
Philips Medical Systems (Cleveland) Inc: Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Recall number
- Z-2117-2016
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Product
- Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
- Status
- Terminated
- Initiated
- 2016-04-01
- Posted
- not on file
- Terminated
- 2018-06-26
- Reason
- Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images. A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
- Root cause
- Software design (manufacturing process)
- Action
- Philips Medical Systems (Cleveland) Inc. sent an Urgent Field Safety Notice letter to affected customers , via certified letter with receipts returned for tracking purposes. The letter identified the affected product, problem and actions to be taken. Philips Healthcare is implementing software update version 3.5.5 to correct the problem. For questions contact your local Philips representative or local Philips Healthcare office.
- Quantity
- 18
- Distribution
- US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
- Lot, serial or model codes
- Ingenuity Core,System Code #728321, Serial numbers: 310101, 310102, 310103, 310104, 310105, 310106, 310108, 310109, 310112, 310115, 310137, 333006, 333008, 333011, 333012, 333013, 333016, 333017, 333023
- 510(k) numbers
- K033326
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 1525965
- Firm city
- Cleveland
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06